FDA disallows generic amlodipine other than Mylan's

The US Food and Drug Administration has confirmed Mylan Laboratories' current status as the only approved Abbreviated New Drug Application for all strengths of amlodipine besylate tablets, the generic form of drug giant Pfizer's Norvasc. The FDA notified Mylan and all amlodipine ANDA applicants that these unapproved products are currently blocked from approval by pediatric exclusivity and if the mandate from the March 21 appellate court decision related to the validity of the amlodipine besylate patent does not issue before September 25 (Marketletters passim).

"Pfizer and Mylan will have no additional competition during the interim period and thus will obtain the full benefit that could be derived under pediatric and 180-day marketing exclusivity," said the latter firm.

The FDA further stated that, in the event an appellate court mandate is issued prior to September 25, the only ANDA eligible for approval during that period will be from Apotex because of the favorable court decision in the Pfizer case.